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Acne clearing cleanser - Medication Information

Product NDC Code 84262-010
Drug Name

Acne clearing cleanser

Type Brand
Active Ingredients
Salicylic acid 2 g/2ml
Route TOPICAL
Dosage Form GEL
Application Number M006
Labeler Name GLYTONE LLC
Packages
Package NDC Code Description
84262-010-01 200 ml in 1 bottle (84262-010-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Salicylic Acid 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Dispense a small amount into hand and mix with a little water. Apply a thin layer over the entire affected area in a circular motion and rinse thoroughly with warm water two times daily. Because excessive dry of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients WATER, METHYLPROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, SODIUM LAUROYL SARCOSINATE, HEXYLENE GLYCOL, CAPRYLOYL GLYCINE, CLEOME GYNANDRA LEAF EXTRACT, POTASSIUM SORBATE, PROPANEDIOL, SODIUM BENZOATE, SODIUM HYDROXIDE, XYLITYLGLUCOSIDE

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For the treatment of acne. Dries and clears acne blemishes and allows skin to heal. Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Acne Clearing Cleanser SALICYLIC ACID LAURIC ACID SODIUM LAUROYL SARCOSINATE POTASSIUM SORBATE WATER SODIUM BENZOATE METHYLPROPANEDIOL SODIUM CHLORIDE PROPANEDIOL CLEOME GYNANDRA LEAF TERT-BUTYL ALCOHOL SALICYLIC ACID SALICYLIC ACID HEXYLENE GLYCOL CAPRYLOYL GLYCINE SODIUM HYDROXIDE XYLITYLGLUCOSIDE EDETATE SODIUM AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL GLYTONE ACNE CLEARING CLEANSER ACNE THERAPY 2% SALICYLIC ACID 200 ML / 6.7 FL. OZ acne

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep ou tof reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store at room temperature of 68-77F (20-25C).

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs. Keep ou tof reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API